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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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06/07/2018 Sterility 14-510 Complete ISO 11137-3 Second edition 2017-06 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
ANSI AAMI ISO 11137-3:2017/(R)2023 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
09/09/2008 Sterility 14-239 Complete ISO 13408-3 First edition 2006-09-15 Aseptic processing of health care products - Part 3: Lyophilization
ANSI AAMI ISO 13408-3:2006/(R)2015 Aseptic processing of health care products - Part 3: Lyophilization
09/17/2018 Sterility 14-513 Complete ASTM F2825-18 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
07/09/2014 Sterility 14-434 Complete ASTM F2228-13 (Reapproved 2021) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method
07/09/2014 Sterility 14-256 Complete ASTM F2095-07 (Reapproved 2021) Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
07/09/2014 Sterility 14-435 Complete ASTM F2251-13 (Reapproved 2023) Standard Test Method for Thickness Measurement of Flexible Packaging Material
07/09/2014 Sterility 14-290 Complete ANSI AAMI ST24:1999/(R)2018 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.
08/21/2017 Sterility 14-502 Complete ISO 11138-1 Third edition 2017-03 Sterilization of health care products - Biological indicators - Part 1: General requirements
ANSI AAMI ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
01/30/2014 Sterility 14-397 Complete AOAC 6.2.04:2013 Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method
01/30/2014 Sterility 14-398 Complete AOAC 6.3.05:2013 Official Method 966.04, Sporicidal Activity of Disinfectants Method I
01/30/2014 Sterility 14-399 Complete AOAC 6.3.06:2012 Official Method 965.12 Tuberculocidal Activity of Disinfectants
01/30/2014 Sterility 14-400 Complete ASTM F2203-13 (Reapproved 2022) Standard Test Method for Linear Measurement Using Precision Steel Rule
01/30/2014 Sterility 14-402 Complete ASTM F1140/F1140M-13 (Reapproved 2020)e1 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
01/30/2014 Sterility 14-404 Complete ASTM F2250-13 (Reapproved 2018) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
01/27/2015 Sterility 14-166 Complete ISO 14644-7 First edition 2004-10-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
09/17/2018 Sterility 14-512 Complete ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products - Part 2: Sterilizing filtration.
ANSI AAMI ISO 13408-2:2018 Aseptic processing of health care products - Part 2:Sterilizing filtration
09/17/2018 Sterility 14-275 Complete ANSI AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness
04/04/2016 Sterility 14-337 Complete ISO 14937 Second edition 2009-10-15 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 14937:2009/(R)2013 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
07/06/2020 Sterility 14-539 Complete ASTM F2475-20 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
12/18/2023 Sterility 14-592 Complete ISO 13408-1 Third edition 2023-08 Aseptic processing of health care products - Part 1: General requirements
09/17/2018 Sterility 14-293 Complete ANSI AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers
08/14/2015 Sterility 14-464 Complete ISO ASTM 51649 Third edition 2015-03-15 Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
08/14/2015 Sterility 14-465 Complete ISO ASTM 51707 Third edition 2015-03-15 Guide for estimating uncertainties in dosimetry for radiation processing
08/14/2015 Sterility 14-463 Complete ISO ASTM 51608 Second edition 2015-03-15 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV
01/30/2014 Sterility 14-403 Complete ASTM F2054/F2054M-13 (Reapproved 2020) Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
01/30/2014 Sterility 14-430 Complete ISO ASTM 51607 Third edition 2013-06-01 Practice for use of an alanine-EPR dosimery system
09/17/2018 Sterility 14-516 Complete ASTM F3039-15 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
12/18/2023 Sterility 14-594 Complete ISO 11607-1 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)]
01/27/2015 Sterility 14-379 Complete ISO 14644-8 Second edition 2013-02-15 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
05/29/2023 Sterility 14-584 Complete ASTM F2391-22 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
07/06/2020 Sterility 14-541 Complete ANSI AAMI ST72:2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
12/21/2020 Sterility 14-550 Complete ANSI AAMI ST67:2019 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
12/21/2020 Sterility 14-552 Complete ISO ASTM 51818 Fourth edition 2020-06 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
07/06/2020 Sterility 14-543 Complete ISO 11139 First edition 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
07/06/2020 Sterility 14-544 Complete ISO 18472 Second edition 2018-08 Sterilization of health care products - Biological and chemical indicators - Test equipment
12/23/2019 Sterility 14-538 Complete ASTM F3357-19 Standard Guide for Designing Reusable Medical Devices for Cleanability
05/30/2022 Sterility 14-579 Complete ISO 17664-2 First edition 2021-02 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices.
12/20/2021 Sterility 14-566 Complete USP-NF M98795_02_01 <55> Biological Indicators -- Resistance Performance Tests
12/20/2021 Sterility 14-567 Complete USP-NF M7414_01_01 <1229.5> Biological Indicators for Sterilization
12/20/2021 Sterility 14-568 Complete USP-NF M98800_01_01 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
12/20/2021 Sterility 14-569 Complete USP-NF M98810_01_01 <71> Sterility Tests
12/20/2021 Sterility 14-570 Complete USP-NF M98830_02_01 <85> Bacterial Endotoxins Test
07/06/2020 Sterility 14-542 Complete ISO ASTM 52628 Second edition 2020-04 Standard practice for dosimetry in radiation processing
01/27/2015 Sterility 14-390 Complete ISO 14644-10 First edition 2013-03-01 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
07/06/2020 Sterility 14-540 Complete ISO 11737-2 Third edition 2019-12 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ANSI AAMI ISO 11737-2:2019 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
12/20/2021 Sterility 14-565 Complete USP-NF M98802_01_01 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
07/06/2020 Sterility 14-545 Complete ISO ASTM 51276 Fourth edition 2019-08 Practice for use of a polymethylmethacrylate dosimetry system
12/21/2020 Sterility 14-554 Complete ASTM F17-20 Standard Terminology Relating to Flexible Barrier Packaging
01/30/2014 Sterility 14-395 Complete ISO 14698-2 First edition 2003-09-15 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)]
07/06/2020 Sterility 14-549 Complete ASTM F3004-13 (Reapproved 2020) Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
07/15/2019 Sterility 14-528 Complete ISO 11137-1 First edition 2006-04-15 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
ANSI AAMI ISO 11137-1:2006/(R)2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)]
12/19/2022 Sterility 14-580 Complete ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]
07/15/2019 Sterility 14-533 Complete ISO TS 19930 First edition 2017-12 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
04/04/2016 Sterility 14-340 Complete ISO 20857 First edition 2010-08-15 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 20857:2010/(R)2015 (Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
05/30/2022 Sterility 14-577 Complete ISO 11737-1 Third edition 2018-01 [Including AMD1:2021] Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
04/04/2016 Sterility 14-333 Complete ISO 17665-1 First edition 2006-08-15 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
07/15/2019 Sterility 14-532 Complete ASTM F3287-17e1 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method
08/21/2017 Software/
Informatics		 13-92 Partial ISO IEEE 11073-10421 First edition 2012-11-01 Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
08/06/2013 Software/
Informatics		 13-54 Partial ISO IEEE 11073-10404 First edition 2010-05-01 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
01/27/2015 Software/
Informatics		 13-71 Partial RII Version 2.48 Logical Observation Identifiers Names and Codes (LOINC)
06/07/2021 Software/
Informatics		 13-117 Partial IEEE Std 11073-40101-2020 Health informatics - Device interoperability Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment.
08/14/2015 Software/
Informatics		 13-73 Partial IHTSDO SNOMED-CT RF2 Release 2015 Systematized Nomenclature of Medicine - Clinical Terms
09/09/2008 Software/
Informatics		 13-19 Complete CLSI LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer Systems
07/06/2020 Software/
Informatics		 13-114 Complete IEEE Std 11073-10101-2019 Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
07/06/2020 Software/
Informatics		 13-115 Complete ISO IEC IEEE 29119-1 First edition 2013-09-01 Software and systems engineering - Software testing - Part 1: Concepts and definitions
01/14/2019 Software/
Informatics		 13-106 Complete IEEE Std 11073-10207-2017 Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
06/27/2016 Software/
Informatics		 13-84 Complete ISO IEEE 11073-10103 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
09/09/2008 Software/
Informatics		 13-18 Complete CLSI LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System
08/21/2017 Software/
Informatics		 13-94 Complete ISO IEEE 11073-10424 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)]
08/06/2013 Software/
Informatics		 13-49 Complete ISO IEEE 11073-20101 First edition 2004-12-15 Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard
08/06/2013 Software/
Informatics		 13-55 Complete IEEE Std 11073-10421-2010 Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
01/14/2019 Software/
Informatics		 13-105 Complete ANSI AAMI SW91:2018 Classification of defects in health software
08/06/2013 Software/
Informatics		 13-56 Complete IEEE Std 11073-10406-2011 Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph
08/21/2017 Software/
Informatics		 13-67 Complete ISO IEEE 11073-10418 First edition 2014-03-01 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)]
01/14/2019 Software/
Informatics		 13-79 Complete IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
12/23/2019 Software/
Informatics		 13-111 Complete IEEE Std 11073-10201-2018 Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model
08/21/2017 Software/
Informatics		 13-96 Complete UL ANSI 2900-1 First Edition 2017 Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements
12/23/2016 Software/
Informatics		 13-87 Complete ISO IEC 15026-2 First edition 2011-02-15 Systems and software engineering - Systems and software assurance - Part 2: Assurance case
07/15/2019 Software/
Informatics		 13-108 Complete IEEE Std 11073-20701-2018 Health informatics - Point-of-care medical device communication - Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding
12/19/2022 Software/
Informatics		 13-123 Complete ANSI NEMA HN 1-2019 American National Standard Manufacturer Disclosure Statement for Medical Device Security
08/06/2013 Software/
Informatics		 13-38 Complete IEC 80001-1 Edition 1.0 2010-10 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ANSI AAMI IEC 80001-1:2010 Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
12/23/2019 Software/
Informatics		 13-112 Complete AAMI TIR97:2019 Principles for medical device security - Postmarket risk management for device manufacturers
04/04/2016 Software/
Informatics		 13-81 Complete IEEE Std 11073-10419:2015 Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
08/21/2017 Software/
Informatics		 13-91 Complete ISO IEEE 11073-10419 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump
07/09/2014 Software/
Informatics		 13-68 Complete ISO 11073-90101 First edition 2008-01-15 Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care test
08/14/2015 Software/
Informatics		 13-76 Complete ISO 11073-91064 First edition 2009-05-01 Health informatics - Standard communication protocol - Computer-assisted electrocardiography
08/06/2013 Software/
Informatics		 13-59 Complete ISO IEC IEEE 15026-4 First edition 2021-10-01 Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle
12/04/2017 Software/
Informatics		 13-99 Complete ISO IEC 15459-2 Third edition 2015-03-01 Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures
07/06/2020 Software/
Informatics		 13-113 Complete IEEE Std 11073-20601-2019 Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol.
01/14/2019 Software/
Informatics		 13-107 Complete ISO 11073-20702 First edition 2018-09 Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services
IEEE Std 11073-20702-2016 Health informatics - Point-of-care medical device communication Part 20702: Medical Devices
08/14/2015 Software/
Informatics		 13-77 Complete ISO IEC 29147 First edition 2014-02-15 Information technology - Security techniques - Vulnerability disclosure
10/19/2020 Software/
Informatics		 13-116 Complete FIRST CVSS v3.0 Common Vulnerability Scoring System version 3.0
12/19/2022 Software/
Informatics		 13-128 Complete IEEE UL Std 2621.2-2022 Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions
12/23/2016 Software/
Informatics		 13-86 Complete ISO IEC 15026-1 First edition 2013-11-01 Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary
08/06/2013 Software/
Informatics		 13-40 Complete ANSI AAMI IEC TIR 80001-2-1 2012 Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks; Practical applications and examples
IEC TR 80001-2-1 Edition 1.0 2012-07 Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples
08/06/2013 Software/
Informatics		 13-44 Complete ANSI AAMI IEC TIR 80001-2-3:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
IEC TR 80001-2-3 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
08/21/2017 Software/
Informatics		 13-97 Complete IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
01/30/2014 Software/
Informatics		 13-63 Complete ANSI AAMI IEC TIR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations
IEC TR 80001-2-4 Edition 1.0 2012-11 Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization
12/04/2017 Software/
Informatics		 13-102 Complete IEC TR 80001-2-8 Edition 1.0 2016-05 Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
12/04/2017 Software/
Informatics		 13-101 Complete ISO IEC 15459-6 Second edition 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings
 
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